A new postoperative infection lawsuit argues that the Sorin 3T cardiac heater-cooler can become easily contaminated, causing infections in surgical patients.

Plaintiffs Benjamin and Maggie H. recently filed a postoperative infection lawsuit against LivaNova PLC and other related entities, alleging that the Sorin 3T cardiac heater-cooler can cause dangerous infections in open heart surgery patients.

In January 2016, Benjamin says he underwent open heart surgery during which the 3T cardiac heater-cooler was used to maintain his body temperature. In March and April of the same year, Benjamin allegedly started to develop fatigue. In May, his symptoms expanded to include persistent fever.

By July, Benjamin was admitted into the hospital after losing 30 pounds since his surgery and experiencing serious side effects, according to the heater-coolerlawsuit. He was diagnosed with an infection and treated appropriately. Cultures were taken for testing to see what type of infection he had.

Doctors confirmed that he had acquired a M. Chimaera infection. The Sorin 3T lawsuit says one of Benjamin’s doctors wrote of the suspected cause in his notes: “Mycobacterium chimaera infection acquired during [Plaintiff’s] surgery in January 2016 with late development of disease – surgery performed at a time infected heater-coolers were likely in use for the operation and late development of disease well-described in the literature.”

Sorin 3T and Infection Risk

Cardiac heater-coolers are water-circulating devices used with a bypass machine to maintain a patient’s body temperature during open heart surgery. However, reports suggest that bacteria may contaminate the water used in these devices and, when aerosolized by the machine, contaminate the surgical field. This contamination can lead to serious infections, the postoperative infection lawsuit claims.

According to the postoperative infection lawsuit, the bacteria causing 3T infections is M. Chimaera, a subspecies of non-tuberculosis mycobacteria. Generally, these bacteria rarely cause illness despite being common in the environment. However, when exposed to delicate internal organs, the bacteria can cause serious infections.

A non-tuberculosis mycobacteria (NTM) infection can take anywhere from several weeks to six years to develop, the postoperative infection lawsuit claims. The most common result is allegedly a dangerous heart infection known as endocarditis. Symptoms of a NTM infection include persistent fever, pain, night sweats, joint and muscle pain, unexplained weight loss, and fatigue.

In June 2016, the FDA issued a safety alert to consumers and physicians, warning that non-tuberculous infections had been associated with the 3T system. The knowledge that 3T heater-coolers may cause postoperative infections has since spread throughout the medical community and become a well known fact. However, Benjamin claims that LivaNova knew about the contamination since 2011 when reports of infections with their heater-coolers started pouring in to federal agencies.

Benjamin accuses the defendants of strict product liability – product defect, strict product liability – failure to warn, negligence – design defect, negligence – manufacturing defect, negligence – failure to warn, negligent misrepresentation, breach of warranties, violation of state consumer protection laws, and loss of consortium. The postoperative infection lawsuit seeks compensatory damages, punitive damages, court costs, and attorneys’ fees.

The 3T Postoperative Infection Lawsuit is Case No. 4:18-cv-01051 in the United States District Court for the Eastern District of Missouri.